Packaging, Labels & Regulations

Posted on November 2nd, 2009

lady reading labels

As of 2006 the FDA made certain requirements for drug product labeling which meant an increase in the size of package inserts. They added the need for certain content to be present on the label and made adjustments to the font sizes and design requirements.

Now add European packaging, labeling and inserts to the mix. Not only are there strict requirements overseas in terms of labeling, but they also have numerous languages to account for. They are now considering the use of expanded content labels instead of having to have various SKUs for different languages. Phew…that’s already a lot to think of…

Just to extend it a little further now…in Europe there is an October 2010 deadline that specifies that some information be printed in Braille on cartons. This deadline will likely be extended even further seeing as there is still much work to be done to establish the proper guidelines as far dot height and measuring dot quality.

This brings up an interesting topic; with all these modifications to the package insert, how will they keep it accurate? What sorts of quality control or label inspection solutions do they have in place? And to even further that, will these changes ever stop long enough for a proper process to be put in place?

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